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Key Documents

PHR1067

Supelco

Carbamazepine

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

5H-Dibenz[b,f]azepine-5-carboxamide

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About This Item

Empirical Formula (Hill Notation):
C15H12N2O
CAS Number:
Molecular Weight:
236.27
EC Number:
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to BP 974
traceable to Ph. Eur. C0450000
traceable to USP 1093001

API family

carbamazepine

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

191-192 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

NC(=O)N1c2ccccc2C=Cc3ccccc13

InChI

1S/C15H12N2O/c16-15(18)17-13-7-3-1-5-11(13)9-10-12-6-2-4-8-14(12)17/h1-10H,(H2,16,18)

InChI key

FFGPTBGBLSHEPO-UHFFFAOYSA-N

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General description

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to in-house working standards.

Carbamazepine is a tricyclic lipophilic compound, with mild anticholinergic activity. It is widely used as an antiepileptic drug for the treatment of simple and complex partial tonic-clonic seizures.

Application

Carbamazepine may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using chromatography techniques.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem/physiol Actions

Anticonvulsant; ligand for the GABAA receptor benzodiazepine modulatory site. Sodium channel inhibitor.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAA6055 in the slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

Pictograms

Health hazardExclamation mark

Signal Word

Danger

Hazard Classifications

Acute Tox. 4 Oral - Repr. 1A - Resp. Sens. 1 - Skin Sens. 1A - STOT SE 3

Target Organs

Central nervous system

Storage Class Code

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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Pharmacology for the Primary Care Provider (2008)
An ultra-sensitive LC method for the simultaneous determination of paracetamol, carbamazepine, losartan and ciprofloxacin in bulk drug, pharmaceutical formulation and human serum by programming the detector
Sultana N, et al.
American Journal of Analytical Chemistry, 04(1), 24-24 (2013)
Development and validation of an HPLC-UV method for the quantification of carbamazepine in rabbit plasma
Mowafy AH, et al.
Saudi Pharmaceutical Journal : SPJ : The Official Publication of the Saudi Pharmaceutical Society, 20(1), 29-34 (2012)
A rapid LC method for the identification and determination of CNS drugs in pharmaceutical formulations
Raggi.A.M, et al.
Journal of Pharmaceutical and Biomedical Analysis, 23(1), 161-167 (2000)
V L Yip et al.
Clinical pharmacology and therapeutics, 92(6), 757-765 (2012-11-08)
Carbamazepine (CBZ) therapy is associated with cutaneous adverse reactions in up to 10% of patients. Predisposition to these hypersensitivity reactions has been linked to the human leukocyte antigen (HLA) genotype. This systematic review determines the strength of these associations and

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